HIP Fracture Oral thromboPROphylaxis (Hip PRO Pilot)

ConditionHip Fractures
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Calgary

About this trial

As our Canadian population ages, hip fractures in these older adults are becoming very common. The best treatment for the majority of these injuries is urgent treatment with surgery. However, the hip fracture itself, the surgery required, and the immobility following these injuries are all risk factors for developing blood clots in the legs (deep vein thrombosis or DVT) and blood clots in the lungs (pulmonary embolism or PE). These complications are a common cause of death in patients with hip fractures and often result in prolonged medical treatment and hospital stays.

Patients with hip fractures who require surgery are traditionally given injectable blood thinners to help prevent blood clots; however, these medications are costly, may not be tolerated well, and can be difficult to take, as prescribed. Oral blood thinning medications are being used more commonly, but it is unknown which of these medications is the most effective in preventing blood clots in patients after a hip fracture.

Thrombelastography (TEG) technology uses a small sample of blood to evaluate a person's clotting ability. Our research has used TEG technology to evaluate blood clotting risk after hip fracture surgery and the investigators have found that platelets may play an important role in abnormal blood clotting after a hip fracture. The investigators have also shown that acetylsalicylic acid (ASA or Aspirin) may help reduce the abnormal platelet hyperactivity associated with blood clotting. This medication warrants investigation for blood clot prevention after hip fracture.

The investigators propose to directly compare different oral medication regimens after hip fracture surgery, in order to determine which is safest and most effective in preventing blood clots. Our multi-disciplinary research team includes physicians, surgeons, and scientists with experience evaluating different medications for blood clot prevention. Our results will help determine the best medical treatment for preventing DVT and PE, which will benefit patients with hip fractures worldwide.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 50 years with a hip fracture (AO-OTA classification 31-A1-A3 and 31-B1-B3) amenable to surgical treatment (presentation to hospital within 24 hours of injury). Patients with additional injuries will be included and any additional injuries will be documented.

Both open and closed fractures will be included, and open fractures will be documented.

Patients on single agent anti-platelet therapy (i.e., acetylsalicylic acid or clopidogrel) will be included.

Signed informed consent or surrogate consent to participate in study.

Disqualifiers

Delayed presentation (over 24 hours between hip fracture and presentation to hospital).

Pathological fractures secondary to primary cancer or metastatic bone disease.

Peri-prosthetic femur fractures.

Received more than two doses of any thromboprophylaxis agent post-operatively, prior to randomization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rivaroxaban 10mg

    Drug

    Rivaroxaban 10mg daily for 35 days post hip fracture surgery

  • acetylsalicylic acid (ASA) 81mg Oral Tablet

    Drug

    acetylsalicylic acid (ASA) 81mg daily for 35 days post hip fracture surgery

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Rivaroxaban 10mgExperimental treatment 1 intervention
Group B: acetylsalicylic acid (ASA) 81mg dailyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment Rate

Mean number of participants recruited per centre per month, calculated based on the total recruitment

Time frame
12 months

Secondary outcomes

1

Treatment fidelity

Adherence to study medication and pilot trial protocol

Time frame
12 months
2

Retention rate

Participant completion of the pilot trial protocol

Time frame
12 months
3

Consent rates

Consent rates for eligible participants who are approached, including reasons for non-consent

Time frame
12 months
4

Trial implementation barriers Questionnaire

Trial implementation barriers will be assessed using an implementation barrier questionnaire developed for this study. The questionnaire will include questions about barriers and challenges related to the following: data capture, study management, study team infrastructure, participant-specific, site-specific, intervention, and study design. The implementation barriers will be summarized at the end of the study.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator